Biowaivers represent a useful alternative to performing in-vivo studies for generic drugs.
This course will help improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations.
This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:
Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.
To find out more about Jean-Michel Cardot, you can watch 'Meet our Trainers' video featuring Jean-Michel on our YouTube channel by clicking here.
The trainer was very experienced with many examples and encouraged time for questions.
The trainer was very knowledgeable and had good presentation skills.
The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.